Our organization reserves the right to designate requirements for verification or validation activities that we or our customer, intend to perform at the external providers' premises.

EPR 07

Our organization reserves the right to approve or specify any designs, tests, inspection plans, verifications, criteria for design and development required by our organization from an external provider.

EPR 08

Our organization reserves the right to approve or specify any special requirements, critical items, or key characteristics.

EPR 09

Our organization reserves the right to approve or specify any test, inspection, and verification (including production process verification).

EPR 10

Our organization reserves the right to approve or specify the use of statistical techniques for product acceptance and related instructions for acceptance by our organization.

EPR 11

Our organization reserves the right to require the need from External providers to:

Implement a Quality Management System and we reserve the right to review and approve the External Providers Quality Management System

Wherever applicable our organization reserves the right to require external providers to show evidence of processes to prevent the use of counterfeit parts.

The External Provider is required to: Notify our organization of changes in product and/or process, changes of suppliers, and changes of manufacturing facility locations, our organization reserves the right to approve such changes.

All External Providers are required to: Flow down to the supply chain the applicable requirements including customer requirements.

Our Organization reserves the right to require External Providers to provide test specimens for design approval, inspection/verification, investigation, or auditing.

Our Organization requires that all External Providers are to retain all records associated with the purchase orders for a minimum of 15 years or as required by contract.

Our organization requires the disposition of such documents to be controlled in accordance with the requirements of applicable QMS’s.

EPR 12

Our organization reserves the right of access by our representatives, our customers, and any regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records.

EPR 13

Our Organization reserves the right to require and request evidence of External Providers ensuring that their personal are aware of:

their contribution to product or service conformity;

their contribution to product safety;

the importance of ethical behavior.

F-843-001 REV A DATED 05/01/17

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